Kornimate/medical-research-clean huggingface dataset:
pulmonarom (bacterial lysates) in respiratory tract infections

Conditions: Respiratory Tract Infections

Summary: primary - to evaluate the efficacy of pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment secondary * to evaluate the efficacy of pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment * to evaluate loss of working or study days after second period of treatment * to evaluate the safety and tolerability of pulmonarom in the population under study


Eligibility criteria:
inclusion criteria: * patients with history of relapse or recurrence of respiratory infections or disease * patients with chronic respiratory disease as asthma, bronchitis or sinusitis exclusion criteria: * patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits * patients who are participating or who have participated in another clinical trial during the previous 3 months * patients who have received immunology response stimulants during the previous 30 days * hypersensitivity the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
endoscopic quality improvement program

Conditions: Adenomatous Polyps; Colorectal Polyps

Summary: effective colorectal cancer (crc) screening relies on early identification and removal of both polypoid and non-polypoid lesions with neoplastic potential. the investigators hypothesize that an intensive training program designed to enhance both recognition and classification of lesions with neoplastic potential, will result in an increase in non-polypoid adenoma detection in addition to and independent of an increase in overall adenoma detection rates.

our endoscopic quality improvement program (equip) was a prospective educational intervention with our staff endoscopist as our study population. the investigators measured adenoma detection rates for a baseline period then randomly assigned half of the endoscopists to undergo equip training. the investigators then examined baseline and post-training study adenoma detection rates (adr's) for all endoscopist (trained and un-trained) to evaluate the impact of training.

Eligibility criteria:
inclusion criteria: * colonoscopies performed at mayo clinic ambulatory surgical center exclusion criteria: * procedures for the indication of acute gi hemorrhage * active colitis * hereditary polyposis syndrome * inflammatory bowel disease * incomplete procedures * procedures with surgically altered anatomy (i.e. prior colectomy) * poor bowel preparation (boston bowel preparation score \<5) were also excluded.

Keywords: quality improvement adenoma detection rate polyp detection rate colonoscopy training colorectal cancer screening
pre-oxygenation with high-flow nasal cannula in caesarian section under general anesthesia

Conditions: Pregnancy Related; Anesthesia; Oxygen Deficiency; Cesarean Section Complications

Summary: the investigators and other groups have demonstrated that high-flow nasal oxygen used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. the investigators also have data from a recent study that indicates that high-flow nasal oxygen might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. the studies investigating the concept of high-flow nasal oxygen has up to this date excluded pregnant women. pregnant woman is a patient group with known difficulties to maintain adequate saturation levels during apnoea. due to smaller functional residual capacity their oxygen stores after preoxygenation are smaller compared to patients with a normal body mass index. the pregnant woman also have a higher oxygen demand and metabolism due to the growing placenta and the fetus. pregnant women are therefore a patient group where a method that could prolong time until desaturation would be even more valuable and potentially could save lives. based on the above, the investigators now aim to conduct a clinical pilot study, where pregnant women undergoing caesarian section under general anesthesia are pre and perioxygenated with high-flow nasal oxygen. data from that group will be compared with patients preoxygenated in a traditional manner with tight facemask. this study is done to evaluate an established technique on a patient category that in theory could gain a lot from it.


Eligibility criteria:
inclusion criteria: 1. adult, \>18 years old 2. caesarian section under general anesthesia. 3. pregnant in week 30 or later 4. capable of understanding the study information and signing the written consent. exclusion criteria: 1. bmi \>45 2. dependency on non-invasive ventilation to maintain oxygen saturation

Keywords: preoxygenation perioxygenation nasal high flow oxygen cesarian sectio
cluster randomized trial of stepped care intervention vs. treatment as usual for patients with depression

Conditions: Depression

Summary: the main aim of the project is the implementation and evaluation of a stepped care model (scm) for patients with depression with 6 treatment options of varying intensity and setting, including innovative technologies (e-mental health, telephone-based psychotherapy). within this complex intervention, patients are treated by a multiprofessional network of health care providers in hamburg, germany. the study compares the scm condition (intervention group) to a control group receiving treatment as usual (cluster randomization on the level of participating general practitioners). it is expected that the scm condition will show better results regarding reduction of mental symptoms, improvement of quality of life, more efficient access to care and better cost-benefit ratio.


Eligibility criteria:
inclusion criteria: * \>4 points on phq-d-9 depression scale * sufficient knowledge of german language * health situation that allows questionnaire completion exclusion criteria: * insufficient knowledge of german language * health situation not allowing questionnaire completion

Keywords: depression stepped care evidence-based medicine health services research psychotherapy complex intervention guideline
evaluation of a website to improve depression literacy in adoldescents

Conditions: Depressive Disorder; Depression in Adolescence

Summary: the aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy (knowledge about depression, which aid the recognition, treatment or prevention of depression) in healthy adolescents. the investigators will examine whether the website improves depression literacy in healthy adolescents aged 12 to 18 years. the investigators will also assess the acceptability of the website among adolescents.

few young people with major depressive disorder seek professional treatment in time. concerns about social stigma, confidentiality, and limited knowledge about mental health conditions, such as depression, or mental health services are some of the main barriers to seek treatment. to address these problems, we developed an evidence-based website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy. to improve depression literacy, the website provides general information about depression as psychiatric disorder in adolescents (e.g., symptoms, causes, course and treatment of depression). furthermore, the website provides information about self-help strategies for depression and prevention of depression; i.e., strategies for promoting mental health (e.g., reducing stress, doing exercise, undertaking positive activities), which are meant to serve as an addition to professional treatments of depression or to promote mental health in adolescents. target groups of the website are adolescents aged 12 to 18 years seeking help for depression, as well as healthy adolescents seeking information about mental health promotion or depression. easy access to information about depression would make early recognition of depression more likely and engage young people to seek help for depression. since the website targets two different groups, the investigators will evaluate the website accordingly: target group 1: adolescents with a major depressive disorder (acute or remitted) target group 2: healthy adolescents (no mental health condition) the current study will focus on target group 2. a study focusing on target group 1 can be found in a separately registered clinical trial on clinicaltrials.gov. the primary aim of this study is to evaluate the efficacy and acceptability of the website "ich bin alles" (https://www.ich-bin-alles.de/) to improve depression literacy in healthy adolescents.

Eligibility criteria:
inclusion criteria: - intelligence quotient (iq) of ≥ 80 exclusion criteria: * current diagnosis of a mental disorder * remitted depressive disorder * insufficient knowledge of german

Keywords: knowledge mental health depression literacy website online adolescence youth
safety of xeloda in solid tumours

Conditions: Metastatic Breast Cancer, Colon Cancer

Summary: the primary objective of this study is to observe safety and tolerability of xeloda as used in medical practice, alone and in combination with docetaxel.


Eligibility criteria:
inclusion criteria: metastatic breast cancer: * women \>=18 years of age * patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. * previous therapy should have included an anthracycline. * patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. * female patients with histopathologically proven metastatic breast cancer * adequate bone marrow, liver, renal and cardiac functions colon cancer: * patients \>18 years of age * patients with histologicaly confirmed colon cancer * patients with potential curative tumor resection within 8 weeks before enrolment in the study * patients previously not treated with chemiotherapy exclusion criteria: metastatic breast cancer: * patients previously treated with docetaxel (taxotere) or capecitabine (xeloda) * patients with contraindications for any of study drugs as listed in approved smpc colon cancer: * patients previously treated with chemiotherapy * patients with contraindications for study drug as listed in approved smpc
use of pulsed low-dose rate re-irradiation for recurrent glioma (pulsar)

Conditions: Glioma

Summary: re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. the dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 gy. the use of unconventional low dose rate pulsed radiotherapy (pldrt) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. the present study therefore aims at evaluating whether the use of pldrt in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 gy.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * ability to express appropriate informed consent to treatment; * diagnosis of cerebral glioma; * histological/radiological confirmation of disease recurrence/relapse; * previous brain-level radiation therapy completed a minimum of 6 months; * performance status: ecog=0-2. exclusion criteria: * refusal to radiation treatment (i.e., absence of informed consent signed); * concomitant chemotherapy; * leptomeningeal spread of disease and localization in both cerebral hemispheres; * current pregnancy.
substantial equivalence study for kai medical non-contact respiratory rate monitors for use with neonates

Conditions: Respiration

Summary: the purpose of this study is to test the accuracy of two devices (the kai spot (v 2.1) and the kai continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

the purpose of this study is to test two remote, doppler radar-based sensors to measure and monitor respiratory rate. specifically, in clinically stable neonatal patients the study aims to: 1. obtain respiratory effort data of neonatal patients with remote doppler radar systems modified from a system cleared by the fda for adult use. 2. determine if remote doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems. 3. determine if unattended doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

Eligibility criteria:
* inclusion criteria: 1. clinically stable * exclusion criteria: 1. clinically unstable * hypotensive requiring pressors * intubated 2. scheduled or planned (e.g., ct scan, central line placement) procedure during the study period.

Keywords: non-contact radar doppler respiratory respiration breathing rate frequency respiratory mechanics respiratory rate measurement apnea sleep apnea
endocrowns as permanent restorations for endodontically treated permanent molars in young age: two-year follow up

Conditions: Endodontically Treated Teeth; Permanent Molars

Summary: background: a real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. for permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? the question most commonly asked. purpose: to evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.

endodontic treatment will be done for all patients using protaper next rotary files and iroot sp sealer. then patients were randomly divided into two groups; gr 1: conventional group (cg), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations. gr 2: endocrown group (eg), the coronal cavity will be restored with ips e.max cad endocrown restorations. * first step: endodontic treatment protocol will be used as the following: 1. biomechanical preparation using; 2.6% naocl for irrigation, protaper next rotary files for instrumentation and 17% edta gel for lubrication. 2. obturation of root canal using; protaper gutta-percha and iroot sp sealer. * second step: endocrown restoration protocol will be used as the following: 1. occlusal butt joint design for endocrown preparation. 2. putty-wash technique for taking impression. 3. ips e.max cad for endocrown construction. 4. g-cem self-adhesive resin cement for endocrown cementation. * follow up visits: the patients will be recalled every 6 months for evaluation. * evaluation methods: * endodontic treatment evaluation: the outcome will be evaluated clinically and radiographically. * endocrown restoration evaluation: the outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.

Eligibility criteria:
inclusion criteria: 1. patients were systemic free. 2. mature lower permanent first molar needs conventional endodontic treatment. 3. the remaining coronal tooth structure after endodontic treatment is not less than 50%. 4. presence of teeth in opposite arch with normal occlusion. 5. absence of para-functional habits. 6. supra-gingival margin after preparation. 7. no known allergies. 8. complaint patient (parent/ guardians) exclusion criteria: 1. immature lower permanent first molar. 2. presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding. 3. lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.

Keywords: endocrown, monoblock restoration, endodontically treated teeth young age
an investigator-initiated study to assess the association of diabetic retinopathy severity scale (drss) with level of decreased corneal sensitivity

Conditions: Diabetic Retinopathy; Neurotrophic Keratitis

Summary: evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

this study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate drss and disease characteristics with corneal desensitization. in addition, to better understand the relationship of disease duration, hba1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.

Eligibility criteria:
inclusion criteria: * have type 1 or type 2 diabetes with drss of 3 or higher * be willing and able to sign the informed consent form (icf) * be at least 18 years of age * be literate and able to complete questionnaires independently * have provided verbal and written informed consent exclusion criteria: * have a history of vitrectomy * have a history of cornea, eyelid, glaucoma, or retina surgery * have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve v pathology, such as trigeminal neuralgia * have a history of ocular herpes simplex virus infection * have a history of herpes zoster ophthalmicus * have a history of ocular chemical trauma * have a history of underlying corneal dystrophies * have had cataract surgery less than 3 months prior * have a history of pan-retinal photocoagulation (prp) * have current stage 2 or 3 neurotrophic keratopathy * have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to visit 1
vitamin d and head and neck cancer: impact on toxicity and prognosis

Conditions: Head and Neck Cancer

Summary: the goal of this observational study is to learn about relation between vitamin d levels in subjects with head and neck cancer. the main question it aims to answer are: * variation of vitamin d levels in the study population at different time points * relation between therapy side effects and vitamin d level * relation between disease outcome and vitamin d level participants will be followed as per clinical practice

there are only a few works in the literature that correlate the circulating levels of vitamin d with the prognosis or development of toxicity in treated hnscc patients with radical intent radiation therapy. these small studies have highlighted a worse outcome and greater toxicity in patients with low vitamin d levels. the study aims to study the variations in circulating levels of vitamin d in a multicenter cohort of patients with hsncc prospectively collected and to evaluate the impact of vitamin d levels at diagnosis on the development of toxicity and on disease outcome

Eligibility criteria:
inclusion criteria: histologically proven hnscc (squamous cell carcinomas), all subsites * non-metastatic locally advanced stages * patients candidate for radical or adjuvant radiotherapy * patients candidate for bilateral neck irradiation * written informed consent exclusion criteria: * distant metastases * patients with known disorders of calcium/vitamin d metabolism
comparison of multifocal electroretinogram assessment in chronic central serous chorioretinopathy (csc) between laser treatment group and photodynamic therapy group in chronic central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: this study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.

1. laser group: extrafoveal focal leakage on fag 2. pdt group: no definite focal leak on fag subfoveal or juxtafoveal focal leakage on fag, or serous retinal pigmentary epithelial detachment involving foveal center inclusion criteria 1. chronic serous chorioretinopathy (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and oct 2. ability to maintain steady fixation for mferg 3. presence of abnormal dilated choroidal vasculature in icga 4. symptom duration over 3 months exclusion criteria 1. previous pdt or laser treatment history 2. evidence of choriinal neovascularization in fag 3. other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies follow-up visit 1)baseline 2)1month 3)3months 4)6 months each visit: multifocal electroretinogram, visual acuity, optical coference timography should be measured.

Eligibility criteria:
inclusion criteria: 1. csc (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and oct 2. ability to maintain steady fixation for mferg 3. presence of abnormal dilated choroidal vasculature in icga 4. symptom duration over 3 months exclusion criteria: 1. previous pdt or laser treatment history 2. evidence of cnv in fag 3. other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies

Keywords: chronic central serous chorioretinopathy multifocal electroretinogram central retinal function after treatment in chronic serous chorioretinopathy
ajmaline utilization in the diagnosis and treatment of cardiac arrhythmias

Conditions: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome

Summary: the study evaluates 3 different populations: it is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of : 1. recent-onset atrial fibrillation versus iv flecainide 2. sustained monomorphous ventricular tachycardia versus iv procainamide the study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of brugada syndrome


Eligibility criteria:
inclusion criteria: * af: patients with isolated, idiopathic, sustained, symptomatic, recent onset(\>10 minutes to \<24 hours) atrial fibrillation. * vt: patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias. * brugada sd (brs): first-degree relatives of a patient with brugada syndrome with a ecg non-diagnostic of the brs. exclusion criteria: * general: pregnancy * af: pre-existing heart disease. * secondary af * 2nd and 3rd degree av block or rbbb associated with lafb or lpfb (bifascicular block). * lvf\<40%. * moderate-severe liver failure. * af with haemodynamic compromise. * vt:vt with haemodynamic compromise. * brs:pre-existing heart disease. * 2nd and 3rd degree av block or rbbb associated with lafb or lpfb (bifascicular block). * moderate-severe liver failure.